Zuranolone: Biogen and Sage Obtain FDA Approval for Postpartum Depression Pill
The Food and Drug Administration of the United States has given approval to the first medication designed to treat postpartum depression.
Biogen (BIIB) and Sage Therapeutics (SAGE) co-developed the medication. The approval had varied results for the businesses. It was not licensed for the treatment of major depressive disorder, which could have made it more marketable to patients.
Zuranolone, a recently approved pill that will be marketed by Sage Therapeutics under the brand name Zurzuvae, complements current medications for postpartum depression.
Currently, brexanolone is also approved for this use, but it must be administered intravenously during a 60-hour hospitalization or medical practice stay.
Zuranolone increases a person’s level of allopregnanolone, a neuroactive steroid that rises during pregnancy and falls precipitously after delivery.
These declines can result in depressive symptoms such as feelings of melancholy, a lack of energy, and in more severe cases, thoughts of self-harm and harming others.
In studies, Zuranolone has been shown to take effect approximately three days after consumption and to have a positive effect that persisted for weeks afterward.
This distinguishes it from antidepressants such as Zoloft and Cymbalta, which typically work by increasing a person’s serotonin levels and have been additionally prescribed to treat postpartum depression in the past.
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Zuranolone Medication Might Not Be The Best Option
A large number of zuranolone trials were conducted on women with extreme postpartum depression; therefore, this drug may not be the most effective option for those with mild to moderate cases.
Zuranolone’s adverse effects include impairment of driving and other hazardous activities, drowsiness, vertigo, diarrhea, exhaustion, the common cold, and urinary tract infections.
Additionally, it may cause suicidal ideation and behavior as well as fetal damage. In addition, its potential impact on breastfeeding infants is uncertain. Nonetheless, this FDA approval is significant.
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